The U.S. Food and Drug Administration (FDA) agency is part of the U.S. Department of Health and Human Services and has jurisdiction throughout the United States. Founded on 30 June 1906 by Theodore Roosevelt and Harvey Washington Wiley, the federal agency is responsible for protecting the public by regulating various human and veterinary products for safety, security, and efficacy. These include different types of food, drugs, medical devices, medical biologics, cosmetics, tobacco products, and radiation-emitting electronic items. With receiving FDA approval, these products cannot be legally made available to the public in the United States.
The Federal Register is the official publication of the U.S. federal government and it publishes the various regulations issued by the FDA to inform the public of agency actions.
FDA regulations are developed from various laws promulgated by the Food, Drug, and Cosmetic Act, the Family Smoking Prevention and Tobacco Control Act, and other legal acts. All the regulations developed by the FDA have the full force of U.S. law behind them.
The U.S. President amended the Federal Food, Drug, and Cosmetic Act by signing legislation on 20 December 2019. As per this amendment, the Tobacco Control Act, the FDA now has the authority to regulate all issues related to the production, marketing, sale, and distribution of tobacco and tobacco-based products.
The FDA raised the legal federal minimum age for buying and using tobacco products from 18 years to 21 years. People under 21 can now no longer legally purchase cigarettes, cigars, e-cigarettes, and other tobacco products from any retailer that has the legal license or permit to sell them.
It is the FDA’s responsibility to protect the rights and safety of the public by ensuring that all the products it regulates follow specified guidelines from production to sale. Towards this end, the FDA monitors the activities of manufacturers in the United States. If they violate any federally mandated rules and that comes to the FDA’s notice, the FDA will issue them an official warning letter.
An FDA warning letter consists of details of the violation and requests a correction from the manufacturer. It also asks the manufacturer to provide a written response after receiving the warning letter. The manufacturer generally must respond to the letter within 15 working days. Depending on what the violation is and the district in which it took place, the manufacturer may be allowed to discuss the matter in detail with the district officials or the center officials.
The FDA does not issue warning letters lightly and U.S. manufacturers are expected by law to take them as seriously and make any necessary changes as soon as possible to alleviate the FDA’s specific concerns. The manufacturers cannot take their products to market unless and until they have dealt with the violations and met FDA compliance.
To inform the general public as well as manufacturers of various federal regulations and warnings, the FDA provides a list of resources on its website.
Manufacturers can find out about FDA compliance requirements that can help them to avoid regulatory actions such as warning letters, financial penalties, and business or product seizures and injunctions.
For instance, in the case of e-cigarette manufacturers, the FDA provides detailed information on how to register their establishment and submit a list of their vaping products, labeling, and advertisements. There are guidances regarding the required warning statements that the manufacturers must legally provide on their product packages and in their advertisements, the ingredient listings they must provide, the potentially harmful product constituents they must report, and the health documents they must submit.
The FDA informs them of the forms and documents they must submit and the fees they must pay. It provides marketing application pathways for manufacturers desiring to launch new products for interstate commerce. They can find out about effective and compliance dates applicable to them.
It provides them with tobacco compliance webinars on updates about tobacco product listing and also gives them access to a database of registered tobacco product manufacturing establishments and their listed products.
Additionally, small manufacturers can get information about the small business assistance they can get from the office of the Center of Tobacco Products.